The following data is part of a premarket notification filed by Iba Dosimetry Gmbh with the FDA for Myqa Ion.
| Device ID | K201798 |
| 510k Number | K201798 |
| Device Name: | MyQA ION |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | IBA Dosimetry GmbH Bahnhofstrasse 5 Schwarzenbruck, DE D-90592 |
| Contact | Andreas Suchi |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2020-07-17 |